Z-2074-2012 Class II Terminated
FDA device recall Z-2074-2012 was initiated by Bridgepoint Medical on June 26, 2012 and is designated Class II. Reason for recall: BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised s… The recall status is terminated (terminated September 6, 2012). Affected quantity: 95 (57 USA, 38 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2012
- Initiation Date
- June 26, 2012
- Termination Date
- September 6, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95 (57 USA, 38 OUS)
Product Description
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
Reason for Recall
BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem.
Distribution Pattern
Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden.
Code Information
Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080